FDLI - Introduction to Drug Law & Regulation
June 22 - 23, 2010
This is the premier course to help you and your organization understand FDA regulations for drug products. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you develop a clearer understanding of how they work. Our experts will provide a broad overview of FDA, the history of drug regulation, and details on specific areas of drug regulation. Additionally, you will examine FDA’s role in managing the drug approval process and how that process governs competition between branded and generic drugs. This program will help you think like an experienced drug professional. You will become more familiar with many of the acronyms used in the drug arena, such as, ANDA, IND, NDA, PDUFA and others. Further, you will gain a clearer understanding of how FDA enforces and implements the laws handed down by Congress. You will learn how all of these provisions and regulations affect what you do every day. This program will also cover the latest topics and important new developments affecting the drug industry, including prescription drug imports, risk management, OTC switches, Hatch-Waxman reform, and more.
Teresa Rea is one of the speakers at this event.
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